NCT02403076

Brief Summary

Unlike the management of patients with various forms of accidents (e.g. polytrauma), only a few data exists for the emergency management of patients with acute gastrointestinal bleeding. The aim of our study is to develop optimal diagnostic and therapeutic algorithms for the management of acute upper and lower gastrointestinal bleedings.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 31, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Last Updated

July 7, 2015

Status Verified

July 1, 2015

Enrollment Period

3 years

First QC Date

March 12, 2015

Last Update Submit

July 6, 2015

Conditions

Gastrointestinal Bleeding

Outcome Measures

Primary Outcomes (1)

  • Time of endoscopy

    The aim of this primary endpoint should reflect whether the timing of endoscopic diagnosis after admission has an impact on the length hospital stay.

    Participants will be followed for the duration of hospital stay, an expected average of 7 days.

Secondary Outcomes (2)

  • Follow up endoscopy (how many patients with gastrointestinal bleeding receive follow-up endoscopy )

    Participants will be followed for the duration of hospital stay, an expected average of 7 days.

  • Endoscopic therapies (whether taking anticoagulants have an impact on the need for endoscopic therapies)

    Participants will be followed for the duration of hospital stay, an expected average of 7 days.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients that will be admitted to our hospital with a gastrointestinal bleeding.

You may qualify if:

  • All patients with suspicion or symptoms of gastrointestinal bleeding.

You may not qualify if:

  • Patients younger than 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ralf Kiesslich, Professor

    HSK Clinic Wiesbaden, Department of Internal Medicine II

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2015

First Posted

March 31, 2015

Study Start

January 1, 2015

Primary Completion

January 1, 2018

Last Updated

July 7, 2015

Record last verified: 2015-07